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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

Welcome to DarshanTalks!We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.We focus on life science issues involving

science life sciences

All Episodes

14:52

You are now the Healthcare Provider - The Future of...

DarshanTalks Podcast ·

2025/04/14

In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transition accelerated by policy changes and rising healthcare costs. Traditionally, employer-provided insurance has been the backbone of the U.S. healthcare system, but evolving regulations, including the Affordable Care Act (ACA), have made individual plans more accessible. This shift has given employees greater flexibility but also placed the burden ...

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3:45

Essential Due Diligence Steps for Clinical Research M&A

DarshanTalks Podcast ·

2025/04/12

When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insightful discussion, Darshan Kulkarni and Edye Edens explore the key legal and operational considerations when acquiring or merging with clinical research entities, including sponsors, sites, and CROs. A major focus of the conversation is understanding the risks associated with clinical trial sites. Many private equity investors are actively looking...

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0:43

Is AI Telemarketing Strategy Illegal?

DarshanTalks Podcast ·

2025/04/10

Today’s episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation tools in your outreach, you could be stepping into a legal minefield under California’s privacy law (CCPA & CIPA). Your telehealth campaign reflects your brand—don’t let privacy lawsuits define it. Contact the Kulkarni Law Firm for a legal review of your telehealth tools to ensure compliance and protect your reputation. Support the show

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18:18

No Clinical Trial Waste

DarshanTalks Podcast ·

2025/04/08

In this episode, Darshan Kulkarni explores an important yet often overlooked question—what happens after a clinical trial ends? While much focus is placed on clinical trials as a care option, the conversation shifts to the opportunities that exist for research-related resources post-trial. Darshan is joined by: Lorri Warren, Program Director of the MedSurplus Alliance at the Task Force for Global Health, which focuses on improving healthcare systems and managing medical product donations.Donn...

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2:34

The Real Meaning of Audit-Readiness in Clinical Research

DarshanTalks Podcast ·

2025/04/06

Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in real time, particularly those with safety or regulatory implications. Being audit-ready means having the infrastructure to identify whether mistakes are isolated incidents or part of a larger trend requiring corrective action. Just like building credit requir...

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3:47

Ordinary People Are Changing Medicine

DarshanTalks Podcast ·

2025/04/04

Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions about safety, ethics, and the future of healthcare, with both promise and complexity. One of the most well-known examples is Lorenzo’s Oil, where ...

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2:19

Investor Influence Can Trigger FCA Violations

DarshanTalks Podcast ·

2025/04/02

Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private equity investors and board members who hold excessive influence over operations. The case of US XRL Martino Fleming vs. South Bay Mental Health Centers serves as a cautionary tale, highlighting how overstepping operational boundaries can lead to False Claims Act (FCA) violations. Investors, eager to enhance efficiency and profitability, may ina...

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2:38

Sponsor to Organization vs. Direct Investigator...

DarshanTalks Podcast ·

2025/03/31

Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability protections, and compliance oversight. These agreements also ensure that investigators have access to institutional resources and support. On the o...

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4:20

Clinical Trial Site M&A: What Most Get Wrong

DarshanTalks Podcast ·

2025/03/29

Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks lie elsewhere—buried in compliance issues that can derail your deal before it even closes. Imagine acquiring a site that looks great on paper, only to face FDA or DOJ scrutiny months later due to undisclosed 483s, protocol deviations, or even kickback violations. Instead of scaling operations, you're dealing with regulatory investigations and pote...

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8:38

Future-Proof Sites: SOS Insights Revealed

DarshanTalks Podcast ·

2025/03/27

In this episode, Darshan Kulkarni sits down with Raymond Nomizu, founder and co-CEO of CRIO, to discuss key takeaways from the SOS conference and the evolving landscape of clinical research. Raymond shares his journey from running a clinical research site to founding CRIO, a platform designed to modernize site operations through eSource, CTMS, and real-time data solutions. They explore major industry trends, including the rise of site networks, increasing sponsor demand for real-time data acc...

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2:29

Why Food M&A Deals Collapse—And How to Prevent It

DarshanTalks Podcast ·

2025/03/25

Darshan talks about a major blind spot in food M&A—hidden compliance risks that can destroy a deal overnight. While most focus on financials, market share, and synergies, they fail to account for regulatory pitfalls that can trigger investigations, recalls, or severe penalties. Imagine being deep in negotiations, only to discover unapproved ingredients, misleading health claims, or an undisclosed FDA warning letter buried in company files. Some executives make the mistake of pushing forwa...

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2:00

Non-Compliance Led to QOL Medical's $47M Settlement

DarshanTalks Podcast ·

2025/03/23

The recent $47 million settlement involving QOL Medical and its CEO is a stark reminder of the consequences of crossing legal and ethical boundaries. Allegations of offering free Carbon 13 breath test kits as kickbacks to induce prescriptions for Sucraid, a treatment for congenital sucrose isomaltase deficiency (CSID), aren't just about non-compliance—they’re about patient safety. The breath tests could not specifically diagnose CSID but were marketed as such, leading to inappropriate prescri...

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2:52

FDA Regulatory Submissions: Challenges, Trends, and...

DarshanTalks Podcast ·

2025/03/21

Edye Edens from KLF offers a brief yet in-depth overview of FDA regulatory submissions for clinical research in the U.S., reflecting on both current practices and predictions for 2025. She highlights how AI tools and evolving political dynamics are shaping the regulatory landscape, emphasizing that while efficiency improvements are necessary, careful and strategic approaches are critical to maintain the FDA’s global reputation and safety standards. Edye discusses the complexity of submissions...

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14:42

How to do a VR promo check - Carly Schaecter gives us...

DarshanTalks Podcast ·

2025/03/19

Carly Schaechter discusses the potential of VR in drug promotion and the challenges of reviewing VR content for the PRC. Key points include the need for VR expertise to conceptualize interactive, engaging content. Choosing VR over AR depends on the objectives, with VR offering more controlled environments. Ensuring user control, addressing misinformation, and learning from past mistakes are crucial for successful VR implementation. Gamification and user experience evaluation are critica...

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5:42

Diversity Matters in Clinical Trials

DarshanTalks Podcast ·

2025/03/18

In this insightful discussion, Shuja Naqvi, CEO of Biopharma Informatics, joins Darshan Kulkarni to explore the evolving landscape of clinical research. Shuja shares how his company has expanded across seven states, strategically choosing locations to promote diversity—not just in ethnicity, but also in socioeconomic and regional representation. He highlights the importance of gathering data from various populations to improve the effectiveness and inclusivity of clinical trials. They delve i...

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2:44

EMA’s LLM Guidelines Impact Life Sciences

DarshanTalks Podcast ·

2025/03/16

The EMA's new guiding principles on LLMs represent a transformative step in regulatory science, addressing both the immense potential and significant risks of these technologies. These principles emphasize the need to balance innovation with ethical considerations, tackling issues like data privacy, misinformation, and bias. LLMs, such as ChatGPT, hold promise for automating workflows like medical translations, pharmacovigilance reporting, and coding support. However, the EMA stresses continu...

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17:08

How to Network Like a Pro at Conferences

DarshanTalks Podcast ·

2025/03/12

In this episode, Darshan sits down with Brook White from CRIO to dive into the value of attending conferences and how to make the most of them. They met at a past conference and quickly realized how much we had to learn from each other, so I asked Brook to come on and share her insights. They start by discussing whether conferences are truly valuable—considering the costs, time investment, and potential for networking. While online learning can be beneficial, conferences offer unique opportun...

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10:35

Getting Ready for SOS 2025: FDA 483s, SOPs, and Site...

DarshanTalks Podcast ·

2025/03/10

In this conversation, Edye Edens and Darshan Kulkarni discuss the excitement and plans for the upcoming Save Our Sites (SOS) Second Annual Conference in Oklahoma City. They highlight the importance of connecting with key industry leaders and peers in person, including names like Dan Sfera, Brad Hightower, and others who have been instrumental voices in the clinical research space. Darshan shares that Kulkarni Law Firm (KLF) will be participating and is excited to engage with attendees, talk a...

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2:13

Maximizing Site Value

DarshanTalks Podcast ·

2025/03/07

When selling a clinical trial site, many owners focus solely on the amount they’ll receive, but the real key is understanding the multiplier that determines your valuation. In M&A transactions, hitting the right EBITDA threshold—such as $3M, $10M, or $25M—can significantly increase your multiplier, turning a 6X valuation into 10X or more. While some claim multipliers as high as 26X, the reality is more complex. Beyond valuation, choosing the right private equity partner is just as critica...

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3:33

5 Key Areas to Review in Clinical Trial Agreements

DarshanTalks Podcast ·

2025/03/05

Contract issues are more common than you think. Edye Edens shares the five critical areas you should always review before signing: Basic Details & Formatting – Ensure names, dates, and references are correct, pages are in order, and there are no typos or inconsistencies from previous templates.Appendices & Exhibits – Verify that referenced documents, such as addendums, exhibits, and budgets, are included and properly linked to the contract.Budget & Payment Terms – Clarify payment ...

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298 results

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